Adverse events and failures with Cerenovus CEREGLIDE 71 Intermediate Catheter: An analytic review of the FDA MAUDE...

Area of Science:

• Neurology
• Medical Device Safety
• Health Informatics

Background:

• The Cereglide 71 aspiration catheter is a recently launched medical device.
• Post-market surveillance is crucial for evaluating new medical technologies.

Purpose of the Study:

• To evaluate the safety and performance of the Cereglide 71 aspiration catheter.
• To identify and analyze adverse events associated with the device using the MAUDE database.

Main Methods:

• Analysis of adverse event reports from the Manufacturer and User Facility Device Experience (MAUDE) database.
• Review of 36 reports (February 2024 onwards) categorized as device-related or patient-related.
• Utilized Microsoft Excel and Jamovi for data analysis.

Main Results:

• Common device-related issues included cracks (8), material bending (6), and deformation (5).
• Adverse patient events comprised thromboembolism (4), intracranial hemorrhage (2), and others.
• Middle cerebral artery stroke was the most frequent indication for device use (9 cases).

Conclusions:

• This is the first report detailing Cereglide 71 complications from the FDA MAUDE database.
• Highlights the importance of ongoing post-market surveillance for improving patient safety.
• Identified specific complications requiring attention in clinical practice for Cereglide 71 use.